PhD Molecular Cell Biology | Senior Scientist Analytical Development: Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases.
Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
PhD Molecular Cell Biology | Senior Scientist Analytical Development
With the company’s recent acquisition of Dimension Therapeutics, the Ultragenyx Gene Therapy division was established.
The Ultragenyx Gene Therapy division is headquartered in Cambridge, MA.
We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy.
Position Summary PhD Molecular Cell Biology | Senior Scientist Analytical Development
This position reports to the Director, Analytical Development and will work with others in the analytical development and quality control teams to develop late-stage assays for AAV efficacy (potency), safety and product quality.
Responsibilities | PhD Molecular Cell Biology | Senior Scientist Analytical Development
- Establish analytical capabilities to drive the company’s AAV vector research and development strategy into action by developing analytical methods to support clinical and commercial development
- Transfer of established methods to internal and external AD and QC departments
- Implement basic AAV analytical characterization and/or QC in-process and lot release methods
- Working with the senior research staff, devise improvements in AAV analytical methods, technology, and analysis platforms in support of cGMP vector manufacturing
- Development, transfer and validation of quantitative cell-based potency assays that measure biological activity
- Prepare, analyze and present technical data
- Prepare and review technical reports and write SOPs
- Work within a cross-functional team to drive programs forward
Requirements | PhD Molecular Cell Biology | Senior Scientist Analytical Development
- PhD in Cell Biology, Molecular Biology, Biochemistry, Virology or a related discipline with 3-6 years industry experience or Masters with 6+ years industry experience.
- Experience in mammalian cell culture, molecular biology, protein biochemistry, biophysical characterization, immunoassays and quantitative PCR methods
- Experience in the development and qualification/validation of late-stage complex biological analytical assays
- Experience with statistical analysis software (SoftMax, JMP, SAS) preferred
- Experience with viral vectors is preferred, and experience with biologics is required
- Experience working with external contract labs (CMOs, CROs) is a plus
- Experience executing late-stage analytical comparability studies is preferred
- Ability and desire to work in a fast-paced, start-up environment
- Strong collaboration and team-working skills
- Strong communication, interpersonal and organizational skills
- Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines